APRIL 2003

WEEK ENDING APRIL 5

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells.
c) Fresh Frozen Plasma.
CODE
a) Units 12H53702, 12P12135, 12P22669, 12Z36587;
b) Unit 12C17518;
c) Units 12P22669, 12Q42637.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC,

REASON Blood products, collected from a donor who was taking the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 4 unit;
b) 1 units;
c) 2 units.
DISTRIBUTION TN, GA, NC, CA, NY, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 04FS44187.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 04W28393.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VT.

PRODUCT Red Blood Cells.
CODE Unit number 71C64414-4.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Gainesville, FL,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit number 04V34102-5.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Gainesville, FL,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT
Platelets Pheresis.
CODE Unit number 084C24862.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA,
REASON Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma (For manufacturing Use Only).
CODE Unit 00SWIB3076.
RECALLING FIRM/MANUFACTURER Community Bio-Resources, Inc., Sheboygan, WI,

REASON Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number 53FC16702.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.

PRODUCT Red Blood Cells, Leukocytes Reduced..
CODE Unit number 29FL64335.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Platelets Pheresis.
CODE Unit number 29FL64335.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA

REASON Blood product, collected using a phlebotomy method that may have compromised the sterlity of the products, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.

b) Recovered Plasma.
CODE a) and b) Unit number 29GP68691.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA
REASON Blood products tested negative for viral markers but were collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC and CA.

PRODUCT Red Blood Cells..
CODE Unit number KS08789.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA,

REASON Blood product collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Platelet, Pheresis, Irradiated (Split unit).
CODE Unit number 035Z12709.
RECALLING FIRM/MANUFACTURER American National Red Cross, The Appalachian Region, Roanoke, VA,

REASON Blood products, labeled as irradiated but did not meet the requirements for irradiation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit number T31342.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,

REASON Blood product, collected from an ineligible donor due to medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT Platelets, Irradiated.
CODE Unit number T92324.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,

REASON Blood product, manufactured from a unit of Whole Blood that was underweight, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Corneas.

CODE ID number 2002-0681, 2002-0682.
RECALLING FIRM/MANUFACTURER Transplant Services Center UT, Southwestern Medical Center, Dallas, TX,

REASON Corneas, collected from a donor who was diagnosed with acute myocarditis, were distributed for transplant.
VOLUME OF PRODUCT IN COMMERCE 2 tissue.
DISTRIBUTION TX.

PRODUCT Recovered Plasma.
CODE Units 12C17518, 12H53702, 12P12135, 12Z36587.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC,

REASON Blood products, collected from a donor who was taking the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TN, GA, NC, CA, NY, and Switzerland.

PRODUCT Red Blood Cells.

CODE Unit number 71E05847-8.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Gainesville, FL

REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT

a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma. .
CODE
a) and b) Unit number 084FT25671.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern California Region, Oakland, CA,

REASON Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.

CODE Unit numbers 42KF08475, 42KF08477, and 42KF08478; and the following units were distributed as two split products: unit numbers 42KF08470, 42KF08471, 42KF08472, 42KF08473, and 42KF08474.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH,

REASON Blood products, possibly exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION OH and MI.

PRODUCT Platelets Pheresis, Leukocytes Reduced.

CODE Unit numbers 42KF08405, 42KF08407, 42KF08408, 42KF08409, 42KF08411, 42KF08412, 42KF08416; and the following units were distributed as two split products: unit numbers 42KF08406, 42KF08417, 42KF08418, and 42KF08421.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH,

REASON Blood products, possibly exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION OH and MI.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Irradiated.

CODE
a) Unit numbers 29FP81221, 29FP81223, 29FP81200, 29FP81209,29FP81199, 29FP81201, 29FP81213, 29FP81223, 29FP81217, 29FP81218, 29FP81225, 29FP81228, 29FP81214, 29FP81215, 29FP81226, 29FP81227, 29FP81220, 29FP81216, 29FP81205, 29FP81212, 29FP81230; and the following units were distributed as two split products: units 29FP81211, 29FP81210, 29FP81202, 29FP81219, and 29FP81204;
b) Unit numbers 29FP81225, 29FP81203, 29FP81222, 29FP81201, 29FP81215, 29FP81220, 29FP81222, 29FP81199, 29FP81206, 29FP81208, and 29FP81214
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA,

REASON Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 31 units;
b) 11 units.
DISTRIBUTION NC, VA, WV, GA, and CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a) b) and c) Unit number R74592.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,

REASON Blood products, collected from an ineligible donor due to use of the medication Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA.

WEEK ENDING APRIL 19

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
B) Fresh Frozen Plasma.
CODE a) 42G39702, 42X62136, 42W28305, 42FJ09119, 42FJ09128;
b) 42Q76487, 42G39702, 42X62136, 42W28305, 42FJ09119, 42FJ09128.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH,

REASON Blood products, corresponding to Platelets that were implicated in a transfusion reaction and positive for Escherichia coli, were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 5 units; b) 6 units.
DISTRIBUTION OH.

PRODUCT Source Plasma.
CODE
G-92677-030, G-99578-030, G-99995-030, G-05303-030, G-06063-030, G-06820-030, G-07024-030, G-08464-030, G-09008-030, G-09260-030, G-09781-030, G-10128-030, G-10738-030, G-11015-030, G-11384-030, G-11670-030, G-12021-030, G-12290-030, G-12719-030, G-12999-030, G-13317-030, F-00119-030, F-00560-030, F-00873-030, F-01239-030.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, CA.,

Manufacturer: Alpha Therapeutic Corporation, Youngstown, OH.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION NC and Spain.

PRODUCT Cornea.
CODE ID number 2003-01-2012.
RECALLING FIRM/MANUFACTURER Heartland Lions Eye Bank, Columbia, OH.,

REASON Human cornea, collected from a donor with discordant Hepatitis B Virus test result, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION MO.

PRODUCT Source Plasma.
CODE Unit numbers 00SWIA2622, 00SWIA3354, 00SWIA3583, 00SWIA4162, 00SWIA5584, 00SWIA5882, 00SWIA6999, 00SWIA7615, 00SWIB0212, 00SWIB1272, 00SWIB1855, 00SWIB3389, 00SWIB3588, 00SWIB4829, 00SWIB5089, 00SWIB5865, 00SWIC0242, 00SWIC2977, 00SWIC3289, 00SWIC4019, 00SWIC4553, 00SWIC5680, 00SWIC6316, 00SWIC9376, 00SWID6969, 00SWID7436, 00SWID8031, 00SWIE6420, 01SWIA1677, and 01SWIA4074.
RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL,.
Manufacturer: Community Bio-Resources, Inc. (now known as BioLife Plasma Services, L.P.), Sheboygan, WI.
REASON Blood products tested negative for the antibody to hepatitis C virus(anti-HCV) but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION Austria.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 18FT60375.
RECALLING FIRM/MANUFACTURER American Red Cross/Great Lakes Region, Lansing, MI.,

REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT a) Red Blood Cells, Leukoreduced.

b) Liquid Plasma.
CODE a) and b) Unit 18226-4565.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.,

REASON Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ and VA.

PRODUCT
a) Red Blood Cell, Leukoreduced.
b) Red Blood Cells.
c) Recovered Plasma.
CODE
a) Units 12GE59530, 12GE57901, 12KE69479, 12GE53417, 12GH97160, 12GH95057, 12GE49248;
b) Unit 12GE47945;
c) Units 12GE59530, 12GE57901, 12KE69479, 12GE53417, 12GH97160, 12GH95057, 12GE49248, 12GE47945.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Regional Blood Services, Charlotte, NC,

REASON Blood products, collected from a donor with a history of Multiple Sclerosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 7 units;
b) 1 unit;
c) 8 units.
DISTRIBUTION AL, CA, NC and Switzerland.

PRODUCT Platelets, Irradiated.
CODE Unit number G05352.
RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Cascade Regional Blood Services, Tacoma, WA,

REASON Blood product, collected from an ineligible donor due to recent ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number V38930.
RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Cascade Regional Blood Services, Tacoma, WA,

REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers LE02356, FK64681, and LE10477.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc, dba: Rhode Island Blood Center, Providence, RI,

REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION RI.

PRODUCT Fresh Frozen Plasma.
CODE Unit number FG65545.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc, dba: Rhode Island Blood Center, Providence, RI,

REASON Blood products, collected from an unsuitable donor due to a history of residing in an area considered at risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, leukocytes Reduced.
c) Platelets, Pooled (1 pool).
CODE
a) Unit number 0857951;
b) Unit number 0883232;
c) Pool number 0081666.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH,

REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units, 1 pool.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) unit number 01Q57350.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY,
REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) 01GN58178.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New York-Penn Region, West Henrietta, NY,

REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY, and CA.

PRODUCT Source Plasma.

CODE Unit numbers GFDRQM, CBZCBC, CBYYBN, CBYXQB, CBMZDS, CBMYYC, CBMXBV, CBMWRX, CBMVNB, and CBMVBZ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc

Manufacturer: Aventis Bio-Services, Inc., Columbus, OH.

REASON Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2) and hepatitis B surface antigen (HBsAg), but were collected from a donor subsequently determined to have previously tested reactive for HIV and HBV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION IL.

PRODUCT Source Plasma.

CODE Unit numbers 46421265, 46422330, 46427694, 46430205, 55973984, 55976299, 55979764, 56721812, 56725117, 56727340, 56450965, 56453430, 56458961, 58292235, 58294000, 58299821, 58302484, and 58308639.
RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL,
Manufacturer: BioLife Plasma Services L.P., Dayton, OH.
REASON Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukoreduced.

CODE Units 04KF56293, 04KF53542.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA,

REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MA, and NY.

PRODUCT a) Red Blood Cells. b) Platelets. c)Recovered Plasma. d)Fresh Frozen Plasma.
CODE
a) and b) Units 04P959310, 71C106262;
c) Unit 04P959310;
d) Unit 71C106262.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL,

REASON Blood products, collected from an unsuitable donor based on a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 2 units;
c) 1 unit;
d) 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells, Leukoreduced

CODE Unit number 40FZ27478.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Heart of America Region, Peoria, IL,

REASON Blood product was not irradiated properly but was distributed with labeling that indicated that the unit had been irradiated.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma. .
CODE
a) Units 71C43146-4, 71C93756-7;
b) and c) Unit 71C93756-7;
d) Unit 71C43146-4.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL

REASON Blood products, collected from a donor who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit number FE79325.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA,

REASON Blood product collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Cryoprecipitated AHF.
d) Plasma, Cryoprecipitate
CODE a), b), c), and d) Unit number 0108892.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH,

REASON Blood products, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OH, and PA.

PRODUCT Recovered Plasma.

CODE Unit number 53GF44774.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, REASON Blood products, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Platelets.

CODE Unit numbers 1956309, 1956410, 1956642, and 1958948.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Centers, Inc., Lexington, KY,

REASON Blood products, collected from an ineligible donor due to recent ingestion of aspirin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION KY.

PRODUCT a )Cryoprecipitated AHF. b)Plasma, Cryoprecipitate Reduced.
CODE a) and b) Unit number 29KL25570.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA,

REASON Blood products, collected from an unsuitable donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA, and NC.

PRODUCT Source Plasma.

CODE Unit numbers G-94688-032, G-94916-032, G-97348-032, G-97564-032, G-97985-032, and G-98185-032.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Charleston, WV,

REASON Blood products, collected from an unsuitable donor based on ear piercing within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.

CODE Units BYDQMT, BYDRZM, BYD SGM, BYDSTG, BYDTBM, BYDVHQ, BYDVST, BYDWGB, BYDWNL, BYDXBY, BYDXKK, BYDZYF, BYFBKD, and BYFBYK.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Charlotte, NC,

REASON Blood products, which tested negative for hepatitis B surface antigen (HbsAg) but were collected from a donor who previously tested repeatedly reactive for HbsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION IL, and Germany.

PRODUCT Source Plasma.

CODE Unit numbers 0530326764, 0530328571, 0530328103, 0530327750, 0530327159, 0530326531, 0530326248, 0530325600, 0530324765, 0530324071, 0530323763, 0530322826, 0530322737, 0530322048, 0530321819, 0530321207, 0530320917, 0530320329, 0530319966, 0530319296, 0530319029, 0530318163, 0530317792, 0530317387, 0530317032, 0530316602, 0530316061, 0530315591, 0530315136, 0530314782, 0530314302, 0530313989, 0530313434, 0530313092, 0530312601, 0530311787, 0530328774, 0530328253, 0530327934, 0530327387, 0530327145, 0530328031, 0530327183, 0530327474, 0530326853, 0530326281, 0530326025, 0530325242, 0530324868, 0530323703, 0530321871, 0530321369, 0530320934, 0530320080, 0530327845, 0530327272, 0530326849, 0530328729, 0530328430, 0530328333, 0530327721, 0530326912, 0530328792, 0530328057, 0530327573, 0530328366, 0530322145, 0530321750, 0530320919, 0530328448, 0530327282, 0530328550, 0530328893, 0530328476, 0530328381, 0530328227, 0530327128, 0530328187, 0530328267, 0530327703, 0530327188, 0530326760, 0530328456, 0530328240, 0530327423, 0530327175, 0530326671, 0530326133, 0530325438, 0530321794, 0530326185, 0530324728, 0530323292, 0530322509, 0530322225, 0530321559, 0530320762, 0530319001, 0530318445, 0530315757, 0530315243, 0530314899, 0530314422, 0530313902, 0530313532, 0530313048, 0530312701, 0530312271, 0530324760, 0530324403, 0530323921, and 0530317793.
RECALLING FIRM/MANUFACTURER Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL,

Manufacturer: ZLB Bioplasma, Inc., Lexington, KY.

REASON Blood products, collected from donors whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 112 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells.

CODE Unit number 9296847.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Red Blood Cells

CODE Unit number 9288868.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA,

REASON Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 units.
DISTRIBUTION LA, and Switzerland.

PRODUCT Red Blood Cells.

CODE Unit number 9338626.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Red Blood Cells.

CODE Units W95041, W95039, W95529, R73771.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA,

REASON Blood products, corresponding to pooled Platelets that were implicated in a transfusion reaction, and tested positive for gram negative rods, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION VA.

PRODUCT Platelet, Pheresis (Split unit).
CODE Unit 084C 25909.
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern California Region, Oakland, CA,

REASON Blood products, which were not manufactured within the acceptable time frame from collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.

CODE Unit number KC12768.
RECALLING FIRM/MANUFACTURER BloodSource -Sacramento (formerly the Sacramento Medical Foundation Blood Center), Sacramento, CA,

REASON Blood product, that was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.

c) Red Blood Cells, Washed

d) Red Blood Cells, Irradiated.

CODE
a) Unit numbers 01FC06931, 01FC07185, 01FC07186, 01FC07187, 01FC07188, 01FC07189, 01FC07192, 01GC46602, 01GC48268, 01GC48269, 01GC49000, 01GC49001, 01GC49002, 01GG34436, 01GG47315, 01GG47631, 01GG50523, 01GG51552, 01GG51553, 01GG51554, 01GG51555, 01GG51602, 01GG51603, 01GG53257, 01GG53545, 01GG53546, 01GG57558, 01GG57564, 01GJ40204, 01GJ40205, 01GL33738, 01GL41669, 01GL44448, 01GL45317, 01GL45318, 01GL45319, 01GL45320, 01GL50131, 01GL50132, 01GL51865, 01GL55946, 01GL55949, 01GL56146, 01GL56410, 01GL56411, 01GN40247, 01GN41540, 01GN41541, 01GN42670, 01GN42677, 01GN43225, 01GN43226, 01GN46659, 01GN49749, 01GN49750, 01GN49751, 01GY41249, 01GY45037, 01GY48353, 01GY51551, 01GY51980, 01GY51981, 01GY51982, 01GY52493, 01GY52713, 01GY52714, 01GY52715, 01GY52716, 01GY53559, 01GY53560, 01GY53696, 01GY54335, 01GY54336, 01GY54337, 01GY55136, 01GY55138, 01GY55588, 01GY55589, 01GY55590, 01GY55591, 01GY55592, 01GY55593, 01GY55594, 01GY55595, 01GY55596, 01GY56024, 01GY56025, 01GY56631, 01GY56632, 01GY57144, 01GY58238, 01GY58237, 01GY58382, 01GY58383, 01GY59125, 01GY59126, 01GY59127, 01GY59129, 01GY59130, 01LC33380, 01LC33385, 01LC34714, 01LC34715, 01LC35807, 01LC35808, 01LC35809, 01LE22616, 01LE22617, 01LE22618, 01LE22687, 01LE22692, 01LE22697, 01LE23471, 01LE23473, 01LE23474, 01LE23475, 01LE23477, 01LE23478, 01LE23810, 01LE23811, 01LE24176, 01LE24177, 01LE24179, 01LE24180, 01LE24181, 01LE24408, 01LE24409, 01LE24471, 01LE24472, 01LE25087, 01LE25088, 01LF07023, 01LF07028, 01LF07301, 01LF07302, 01LH36320, 01LH36767, 01LN20930, 01LN21252, 01LN21253, 01LN21976, 01LN21977, 01LN22430, 01LN22431, 01LN22426, 01LN24735, 01LN24736, 01LP40052, 01LP40053, 01LS24347, 01LS27007, 01LS27040, 01LS27759, 01LS27761, 01LS28059, 01LS28060, 01LS28061, 01LS28352, 01LS28353, 01LS28355, 01LS30230, 01LS30231, 01LS30382, 01LS30383, 01LS30384, 01LS30385, 01LS30386, 01LT29415, 01LT29416, 01LT31048, 01LT31049, 01LT31451, 01LT31452, 01LV36450, 01LV37608, 01LV41382, 01LV42207, 01LV42389, 01LV42386, 01LV42491, 01LV43664, 01LV43665, 01LV43666, 01LV43667, 01LW20365, 01LW20366, 01LW20363, 01LW20361, 01LW20431, 01LW22573, 01LW22572, 01LW22568, 01LW22567, 01LW23627, 01LW24124, 01LY13193, 01LY14689, 01LY14690, 01LY14691, 01LY14692, and 01Y26249;
b) Unit numbers 01GN49355, 01GN49354, 01GN59157, 01GN59155, 01GY68152, 01GY68153, 01GY68154, 01GY68155, 01LC41079, 01LE28742, and 01LE28739;
c) Unit number 01LW24123;
d) Unit numbers 01LV42490 and 01LY13192.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New York-Penn Region, West Henrietta, NY,

REASON Blood products, manufactured by a method that may have resulted in the products being out of specification for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 201 units;
b) 11 units;
c) 1 unit;
d) 2units.
DISTRIBUTION NY, PA, and MD.

PRODUCT a) Red Blood Cells, Leukocytes Reduced Irradiated.
b) Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE a) Unit number 035FC45849; b) Unit number 035P37754.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Appalachian Region, Roanoke, VA,

REASON Blood products that were possibly exposed to unacceptable temperatures when removed from controlled storage for irradiation were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT Red Blood Cells.

CODE Unit 8231911.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN,

REASON Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT a) Platelets.
b) Platelet, Pheresis.

CODE
a) Units 18FS65072, 18FS65077, 18FV42377, 18FZ30105, 18GN17108, 18N82282;
b) Units 18P50566, 18P50563, 18P50562, 18P50557, 18P50556, 18P50558, 18P50560.
RECALLING FIRM/MANUFACTURER American Red Cross, Great Lakes Region, Lansing, Michigan,

REASON Blood products, which were exposed to room temperature for an unacceptable resting time, were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 6 units; b) 7 units.
DISTRIBUTION MI.

PRODUCT Recovered Plasma.

CODE Unit number 9288868.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA,

REASON Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 units.
DISTRIBUTION LA, and Switzerland.

WEEK ENDING APRIL 26

PRODUCT a) Platelets. b) Platelets, Irradiated. c) Fresh Frozen Plasma. .
CODE a) Unit numbers G02226, L23641, R15276, R15277, R15278, R15279, R15280, R15282, V42570, and V44411;
b) Unit numbers G02225, G02228, T12226, T12227, and V42571;
c) Unit numbers P68212, P68213, P70563, T12225, T12226, and T12227.
RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Cascade Regional Blood Services, Tacoma, WA

REASON Blood products, prepared more than eight hours after collection of the corresponding units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 10 units;
b) 5 units;
c) 6 units.
DISTRIBUTION WA, WI, and SC.

PRODUCT Source Plasma.
CODE Unit number DZDSJP.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Eugene, OR,

REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Unit number 71862835.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Salem, OR.
REASON Blood product, that tested negative for human immunodeficiency virus (HIV) p24 antigen, but was collected from a donor that subsequently tested repeatedly reactive for HIV p24 antigen, was not properly quarantined and was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 46405975, 46408389, 47151369, 47155527, 46989093, 46985385, 47205734, 47208797, 57403298, 57406237, 57342504, 57346779, 57757483, 57759104, 59418740, 59222613, 59227588, 59187264, 59359463, and 59111467.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Salem, OR,

REASON Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit number 0551094.
RECALLING FIRM/MANUFACTURER Nalani 2 Outpatient Oncology, Honolulu, HI,

REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION HI.

PRODUCT Source Plasma.
CODE Unit number G-12679-030.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA,

REASON Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.

PRODUCT a) Hepatitis B Virus Core Antigen (Recombinant) Diagnostic Kit, Corzyme.
b) Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Diagnostic Kit, Auszyme_ Monoclonal.
c) Hepatitis C Virus Encoded Antigen (Recombinant c100-3, HC-31, and HC-34) Diagnostic Kit, Abbott HCV EIA 2.0.
CODE
a) Lot number 92847M300;
b) Lot numbers 92549M302, 93157M302, 92549M300, 92549M301, and 93157M300;
c) Lot number 93786M200.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park, IL,

REASON Hepatitis B and C test kits contained conjugate or conjugate diluent vials that could leak.
VOLUME OF PRODUCT IN COMMERCE
a) 1 lot;
b) 5 lots;
c) 1 lot.
DISTRIBUTION Nationwide, and Thailand and Singapore.

PRODUCT Red Blood Cells Leukocytes Removed.
CODE Unit 12GY47495.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Carolinas Region, Charlotte, NC.
REASON Blood product, which tested positive for anti-E antibodies but was labeled as negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT a) Gammazyme-F_ (Stable Ficin Solution).
b) Ficin Solution.
CODE
a) Lot EF50-1;
b) Lot ENZ137 (component of Ficin Panel One System Package, lots 0122802, 0205814, 0219853, 0305866, 0319903, 0402916, 0416954, 0430966, and 0514004; and Ficin Panel Two System Package, lots 0212827, 0312878, 0409928, and 0507979).
RECALLING FIRM/MANUFACTURER Gamma Biologicals, Inc, Houston, TX,

REASON Ficin reagent, which exhibited a loss in potency during post-release testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 923 vials;
b) 3241 vials.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Source Plasma (For Manufacturing Use).
CODE Unit number 71909844.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Lakewood, WA,

REASON: Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Misys Laboratory_ Blood Bank System computer software (3 versions).
CODE Version numbers 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ,

REASON Blood bank computer software contained a defect that could result in the incomplete displaying of red blood cell antigen and antibody information for a unit of blood.
VOLUME OF PRODUCT IN COMMERCE 3 versions.
DISTRIBUTION Nationwide, United Kingdom, Ireland, Canada, Bermuda, and Saudi Arabia.

PRODUCT a) Red Blood Cells. b) Platelets. .
CODE a) and b) Unit number FT97394.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA

REASON Blood products, that tested initially reactive for human immunodeficiency virus (HIV) p24 antigen, was not appropriately retested in duplicate and was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD, and Washington D.C.